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Evaluation of POC Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment

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ClinicalTrials.gov Identifier: NCT03076450
Recruitment Status : Unknown
Verified April 2017 by Qiancheng Luo, Shanghai Pudong New Area Gongli Hospital.
Recruitment status was:  Recruiting
First Posted : March 10, 2017
Last Update Posted : May 2, 2017
Sponsor:
Collaborator:
Shanghai Municipal Commission of Health and Family Planning
Information provided by (Responsible Party):
Qiancheng Luo, Shanghai Pudong New Area Gongli Hospital

Brief Summary:
Using lung ultrasound re-aeration score(LUS-RAS) combined with pressure-volume curve(PVC) adjust maintain positive end-expiratory pressure(PEEP) after recruitment maneuver, to achieve real-time adjustment, reduce ventilation-associated lung injury and the purpose of effective lung recruitment.

Condition or disease Intervention/treatment Phase
Acute Respiratory Distress Syndrome Device: Lung Ultrasound Diagnostic Test: Maximum Oxygenation Not Applicable

Detailed Description:
The traditional method, set PEEP according to PVC in ARDS mechanical ventilation, lacks morphological evaluation. For point-of-care lung ultrasound(POC-LUS) is non-invasive, real-time, visualization, no need transport patients, getting more and more attention in the ARDS treatment. It has been reported that LUS-RAS is a meaningful assessment in recruitment maneuver. This study will combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP. Using the POC-LUS and maximum oxygenation method to assess lung recruitment effect in experimental group and control group prospectively. The ventilator parameters, state of hemodynamic, arterial blood gas(ABG) in each group will be recorded; Statistical methods will be performed in term to understand the correlation.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Clinical Evaluation of Point-of-care Lung Ultrasound Combined With Pressure-volume Curve to Titration Adjust PEEP for ARDS Lung Recruitment
Actual Study Start Date : March 1, 2017
Estimated Primary Completion Date : March 1, 2018
Estimated Study Completion Date : September 1, 2018


Arm Intervention/treatment
Active Comparator: Maximum Oxygenation
Using PVC to set the initial peep, check ABG real-time, and according to PaO2+PaCO2≥400mmHg whether or not to adjust maintain PEEP.
Diagnostic Test: Maximum Oxygenation
Adjust PEEP real-time in term of PaO2+PaCO2≥400mmHg whether or not.

Experimental: Lung Ultrasound Re-aeration Score
Combine POC-LUS with PVC in set the initial peep, and then dynamic record LUS-RAS to feedback regulate PEEP.
Device: Lung Ultrasound
Adjust PEEP real-time in term of LUS-RAS chang.




Primary Outcome Measures :
  1. Lung Ultrasound re-aeration score, LUS-RAS [ Time Frame: 48 hours ]
    The score is composed of 12 different regions of chest wall checked by POC-LUS.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patient aged 18 years and older
  • ARDS patients with invasive mechanical ventilation

Exclusion Criteria:

  • Intracranial hypertension
  • Pneumothorax and mediastinal emphysema
  • Severe hypoxemia (oxygenation index <100)
  • Hemodynamic instability
  • Chest deformity or surgical history
  • Affect Lung-ultrasound conditions: subcutaneous emphysema, chest wound etc.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03076450


Contacts
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Contact: Qiancheng Luo, MM 008613564781737 luoqiancheng19@163.com

Locations
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China, Shanghai
Gongli Hospital Recruiting
Pudong, Shanghai, China, 200135
Contact: Qiancheng Luo, MM    008613564781737    luoqiancheng19@163.com   
Sponsors and Collaborators
Shanghai Pudong New Area Gongli Hospital
Shanghai Municipal Commission of Health and Family Planning
Investigators
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Principal Investigator: Qiancheng Luo, MM Shanghai Pudong New Area Gongli Hospital

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Responsible Party: Qiancheng Luo, Attending-doctor of Critical Care Medcine, Principal Investigator, Shanghai Pudong New Area Gongli Hospital
ClinicalTrials.gov Identifier: NCT03076450     History of Changes
Other Study ID Numbers: 201640405
First Posted: March 10, 2017    Key Record Dates
Last Update Posted: May 2, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by Qiancheng Luo, Shanghai Pudong New Area Gongli Hospital:
Acute respiratory distress syndrome, ARDS
Point-of-care lung ultrasound,POC-LUS
Pressure-volume curve, PVC
Positive end-expiratory pressure, PEEP
Ultrasound re-aeration score, US-RAS
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Acute Lung Injury
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Lung Injury